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AQuify Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic)lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify Multipurpose Solution is also indicated for daily protein removal when used with the no rub directions for use.

AQuify Multi-Purpose Solution is a sterile aqueous solution containing dexpanthenol, preserved with polyhexanide 0.0001%. pluronic F127, edetate disodium dehydrate, sorbitol, tromethamine, sodium phosphate dihydrogren, and purified water.

The provided text describes the safety and effectiveness studies for AQuify Multipurpose Solution, comparing it to predicate devices, particularly ReNu Multipurpose Solution. Here's an analysis of the acceptance criteria and study details based on the input:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with pass/fail thresholds. Instead, it describes studies and their findings, concluding that AQuify Multipurpose Solution is "substantially equivalent" to the predicate device. The performance is reported in terms of statistical significance and preference compared to the control.

Here's a table summarizing the findings as they relate to implied acceptance:

Study Details

The primary study mentioned for clinical evaluation is a "three-month prospective, randomized, single masked trial."

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a number. The text mentions "over 50% of the subjects expressing a preference" by the final visit, suggesting a sizable cohort was involved, but the exact N is not provided.
   • Data Provenance: Prospective. The study was a "three-month prospective, randomized, single masked trial." Country of origin is not specified but implicitly in the USA as it's a 510(k) submission to the FDA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document describes a clinical trial where subjects reported symptoms and efficacy scores, and an "investigator appraisal" for lens deposits and wetting.
   • Number of Experts: Not specified.
   • Qualifications of Experts: The "investigator" who performed appraisals would likely be an eye care professional (e.g., optometrist or ophthalmologist), but specific qualifications (e.g., years of experience) are not provided. The subjects themselves provided "ground truth" for subjective measures like comfort and dryness.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Adjudication methods like 2+1 or 3+1 are typically for reconciling discrepancies in expert interpretations of images or findings. This study primarily relies on direct subject reporting of subjective measures and investigator appraisal for objective measures.
   • Adjudication Method: Not applicable/Not mentioned. The study design ("single masked trial," "contra-lateral basis") means subjects compared the products on their own eyes, minimizing the need for adjudication of differing subjective experiences. Objective appraisals (e.g., dark field image analysis) would have predefined criteria.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • MRMC Study: No, this was not an MRMC study. This study evaluated the performance of a contact lens solution, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance: Not applicable. This device is a contact lens solution, not an algorithm. Its performance is evaluated through direct use (cleaning, disinfection, clinical comfort/dryness) or laboratory testing (microbiology, water content).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For Clinical Efficacy/Safety: Subjective self-reported data from study participants (e.g., comfort scores, dryness scores, preferences) and objective investigator appraisal (lens deposits, front surface wetting, dark-field image analysis).
   • For Microbiology/Cleaning/Dehydration: Laboratory standard tests, likely with pre-defined pass/fail criteria from regulatory guidance (e.g., FDA guidance, USP standards).

7. The sample size for the training set:

   • Not applicable. This is a medical device (contact lens solution), not a machine learning model, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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Karats Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

Karats Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, edetate disodium dihydrate and preserved with polyhexanide 0.0001%.

The provided document describes the 510(k) summary for "Karats Multipurpose Solution." It details preclinical and clinical studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Generally, acceptance criteria for medical devices like contact lens solutions are predefined benchmarks or thresholds the device must meet to be considered safe and effective. While the document mentions meeting standards and demonstrating substantial equivalence, it does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes results and comparisons to a predicate device.

Based on the text, here's an attempt to infer and present the information in a table format, focusing on what was evaluated and the general outcomes:

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